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Surgical Trials (surgical + trials)

Distribution by Scientific Domains
Medical Sciences100%

Selected Abstracts

Reporting of minimum clinically important differences in surgical trials

ANZ JOURNAL OF SURGERY, Issue 4 2009
Irwin Kashani
Background:, The minimum clinically important difference (MCID) is the smallest difference in outcome between the groups that would be of clinical interest. It influences the estimates that are made to determine the required sample side. The aim of this study was to explore the reporting of the MCID in surgical trials. Method:, Surgical trials that were published between January 1981 and December 2006 in five prestigious surgical journals were evaluated. Selected for study were trials that studied two groups and reported the main outcome event as a proportion. Results:, Only 21% (100/486) of the admissible surgical trials mentioned a value for the MCID when estimating the sample size. There was a trend, however, for compliance with these factors to increase during the study period. The present post-hoc calculations of the required sample size, which were based on the observed differences between the groups at the end of the study, suggested that one-third of the trials should have accrued at least fivefold the number of patients. Although reporting an estimate of the sample size was associated with the study of more patients (median sample size 145 vs 100), it was not associated with the reporting of more positive results, that is, 61% (95/155) versus 65% (214/331). Conclusion:, There has been an improvement in the proportion of surgical trials reporting formal estimates of sample size during the last three decades. But the construct of these estimates is often suspect because of a failure to provide realistic values for the MCID. [source]

Pre-clinical remote telesurgery trial of a da Vinci telesurgery prototype

THE INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY, Issue 4 2008
Christopher Nguan
Abstract Background The objective of this study was to perform a pre-clinical remote telesurgery trial of a da Vinci® telesurgery prototype on a surgical-grade virtual private network. Methods A da Vinci telesurgery-enabled prototype was used to conduct surgical trials across a 17 MB/s bandwidth VPNe network spanning 2848 km round-trip landline distance from London, Ontario, to Halifax, Nova Scotia, Canada. The outcomes measured during the trial were surgical times and quality of anastomoses. Results Network configuration resulted in observed latencies of 370 ms with 140 ms due to transport delay. The da Vinci telesurgery prototype performed well subjectively and average porcine pyeloplasty anastomotic times were 20.7 ± 4.7 min. Conclusions This work constitutes an early evaluation of the da Vinci telesurgery prototype for conceptually remote telesurgical operations. This study clearly demonstrated the feasibility of remote telesurgery using the da Vinci platform to perform a complex surgical task. Copyright © 2008 John Wiley & Sons, Ltd. [source]

Primum non nocere and randomised placebo-controlled surgical trials: a dilemma?

ANZ JOURNAL OF SURGERY, Issue 7-8 2009
DNB (Ortho), Thomas J Kishen MBBS
No abstract is available for this article. [source]

Reporting of minimum clinically important differences in surgical trials

ANZ JOURNAL OF SURGERY, Issue 4 2009
Irwin Kashani
Background:, The minimum clinically important difference (MCID) is the smallest difference in outcome between the groups that would be of clinical interest. It influences the estimates that are made to determine the required sample side. The aim of this study was to explore the reporting of the MCID in surgical trials. Method:, Surgical trials that were published between January 1981 and December 2006 in five prestigious surgical journals were evaluated. Selected for study were trials that studied two groups and reported the main outcome event as a proportion. Results:, Only 21% (100/486) of the admissible surgical trials mentioned a value for the MCID when estimating the sample size. There was a trend, however, for compliance with these factors to increase during the study period. The present post-hoc calculations of the required sample size, which were based on the observed differences between the groups at the end of the study, suggested that one-third of the trials should have accrued at least fivefold the number of patients. Although reporting an estimate of the sample size was associated with the study of more patients (median sample size 145 vs 100), it was not associated with the reporting of more positive results, that is, 61% (95/155) versus 65% (214/331). Conclusion:, There has been an improvement in the proportion of surgical trials reporting formal estimates of sample size during the last three decades. But the construct of these estimates is often suspect because of a failure to provide realistic values for the MCID. [source]

Evolution of methodological standards in surgical trials

ANZ JOURNAL OF SURGERY, Issue 10 2005
Carleen Ellis
Background: The Consolidated Standards of Reporting Trials (CONSORT) Statement outlines acceptable ways of performing and reporting clinical trials. The objective of the present study was to identify evolving patterns in the methodological standards of surgical trials. Methods: Compliance with 12 key standards from the CONSORT statement were evaluated in 490 trials published in either the ANZ Journal of Surgery or the British Journal of Surgery between January 1969 and December 2003. Results: There has been an irregular but progressive improvement in the methodological standards of published trials. The criteria with the greatest improvement related to estimation of sample size, randomization, concealment of the allocated intervention, baseline comparisons, and the method of expressing outcomes. Compliance rates were <50% for three criteria during the last decade of the review, that is, concealment of the allocated intervention, blindness of assessment, and the method of expressing outcomes. Conclusion: The results of surgical trials need to be interpreted with care. [source]

Gynaecological surgery from art and craft to science?

AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 2 2009
Neil Philip JOHNSON
Randomised controlled trials are applied more readily to medical than surgical interventions. There are even more barriers to randomised trials of surgical interventions than to other randomised trials. These include reluctance among surgeons to undertake trials (owing to concern over expressing equipoise, surgical training and surgical learning curve issues, restrictions of funding and time for research, even financial conflict of interest), reluctance of patients to participate in surgical trials owing to fears over ,experimental surgery', failure of randomised trials to detect rare surgical complications and the almost universal failure of those conducting surgical trials to examine important long-term outcomes. Rapid advances in surgical fields mean that new surgical techniques are rapidly superseded and clinical questions surrounding new techniques may linger only until the next new technique becomes available. Nonetheless randomised controlled trials remain the cornerstone of evaluating the effectiveness of surgical interventions. Genuine progress has been made in this field. However, large multicentre collaborative randomised trials that have been prospectively defined in trial registries will be required in the future to answer the important clinical questions regarding gynaecological surgical interventions. [source]